MAUDE Adverse Event Report: ZYNO MEDICAL LLC ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM; LARGE VOLUME INFUSION PUMP

Model Number	Z-800W
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913); Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is still waiting for the arrival of the device.
Event or Problem Description
The user reported an under infusion issue with the device on (b)(6) 2017."an iv pump that isn't working.Actually it works, but when we program it, it does what it wants to not what its programmed to do.The secondary infusion was zero'd out.The pump # is (b)(4).We set the pump with time/volume or rate/volume.In this case a 500cc bag was to run over 1 hour.1 hour later, there was still about 350cc left in bag when it should have been empty.This has happened several times lately.I rechecked the settings when i noticed this and settings were correct.Yes, pt was involved.She was receiving the med that was to infuse over 1 hour.No injuries.It was given slower.If it would have gone faster, there could have been a problem.I had a patient a couple of weeks ago that something similar happened.I assumed the pump was set incorrectly.Pump alarmed infusion was over, but there was still quite a lot to infuse.No issues for pt, except they had to wait longer for infusion to complete.I didn't think anything of it, since on rare occasions, pumps are set incorrectly." no specific event date was provided by the reporter.No patient injury or harm occurred for this case.
Additional Manufacturer Narrative
The user reported under infusion issue was confirmed.The device was found to have a flow rate accuracy of -5.75%, which was outside of the +/-5% specification.In addition to the under infusion issue, the device was also found to have a battery outside of warranty and a wireless board connection issue; neither of these issues were related to the user-reported under infusion issue.The device was recalibrated, repaired, and tested to meet all specification on (b)(6) 2017.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00313).

• Brand Name: ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
• Common Device Name: LARGE VOLUME INFUSION PUMP
• Manufacturer (Section D): ZYNO MEDICAL LLC; 177 pine street; natick MA 01760
• MDR Report Key: 7061635
• Report Number: 3006575795-2017-00313
• Device Sequence Number: 1423425
• Product Code: FRN
• UDI-Device Identifier: 00814371020020
• UDI-Public: 00814371020020
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: Z-800W
• Device Catalogue Number: Z-800W
• Device Lot Number: 20130918-SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1